UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012932 |
|---|---|
| Receipt number | R000015108 |
| Scientific Title | Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer |
| Date of disclosure of the study information | 2014/01/25 |
| Last modified on | 2014/01/23 19:01:06 |
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Basic information
Public title
Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer
Acronym
Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer
Scientific Title
Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer
Scientific Title:Acronym
Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Psychosomatic Internal Medicine | Geriatrics | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The improvement in quality of life (QOL) by a palliative care team intervention was analyzed in patients with advanced lung cancer. An evaluation of QOL by the patients was compared with its estimation by the attending physicians.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The primary endpoint is the difference between the QOL that was assessed by the EORTC QLQ c-15-PAL after 12 weeks after the start of the test and at the beginning of the study.
Key secondary outcomes
Secondary endpoint is the change of each QOL item and an evaluation of QOL by the patients was compared with its estimation by the attending physicians.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The attending physician will follow-up items of two points from 1 with OPTIM published"STEP palliative care". Attending physician to perform the consultation the PCT if the patient's symptoms were exacerbated. Palliative care team to follow-up items four points from three. Patients make an appointment with the palliative physician, Palliative physician to determine the contents of treatment and the need for specialized outpatient consult.We will do the intervention of one or more times to a minimum one month after the start of the test. We will end the investigation by evaluating the QOL survey again to attending physician and the patient himself after 12 weeks.Patients can choose stop and continued follow-up of 12 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients 20 years old or more.
2.Newly diagnosed patients with stage 4 lung cancer.
3.PS of Eastern Cooperative Oncology Group is 0 to 3.
4.Patients can be expected survival of more than a month.
Key exclusion criteria
1.There is a depression at the start of the test time is patient.
2. It is not possible for the patient to understand Japanese.
3.Patient is not able to visit once a month to our hospital.
4.If the attending physician was deemed inappropriate to participate in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunikane Hiroshi |
Organization
Yokohama Municipal Citizen Hospital
Division name
Department of Palliative Medicine
Zip code
Address
56 Okazawa-cho Hodogaya-ku yokohama-shi Kanagawa-ken Japan
TEL
045-331-1961
taroman045@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Yokoyama |
Organization
Yokohama Municipal Citizen Hospital
Division name
Department of Palliative Medicine
Zip code
Address
56 Okazawa-cho Hodogaya-ku yokohama-shi Kanagawa-ken Japan
TEL
045-331-1961
Homepage URL
taroman045@gmail.com
Sponsor or person
Institute
Yokohama Municipal Citizen Hospital Department of Palliative Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama Municipal Citizen Hospital Department of Palliative Medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama Municipal Citizens Hospital Department of Respiratory Palliative Medicine Yokohama Municipal Citizens Hospital Department of Medical Oncology Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 23 | Day |
Last modified on
| 2014 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015108
